Tuesday, July 5, 2011

Executive Spotlight: David Shuey, The Willis Group

David Shuey
David Shuey, executive vice president and North America practice leader for The Willis Group’s life sciences practice, thinks “startups now realize they can’t be one-trick ponies – they have to have multiple product candidates in the pipeline.” With 19 years of hands-on experience serving the life sciences industry, he should know. His clients range from early-stage R&D companies to large pharmaceutical firms. Shuey has expertise in therapeutics, medical device, generics, nutraceuticals, consumer products, contract research organizations, laboratories and contract manufacturing. His focus is on casualty lines, particularly product liability and international human clinical trials. Read below to find out how Willis Group’s unique technology platform has helped companies of all sizes remain competitive in the global economy.

Q: Within Willis, how big is the life sciences practice?
A: We are a $3.5 billion revenue public company. Within Willis, life sciences is a large practice and a focus. I think management sees it is a growing area. We’re going to need new medical devices and therapeutics no matter what happens.

Q: Tell me a little about your focus at The Willis Group.
A: I have been with Willis for 22 years with 19 of those focused in life sciences. I started off in medical practice liability for doctor groups and integrated health systems. At the time, I was working in the Baltimore area, around D.C. and the northern Virginia area, and a lot of VC money was coming into the area. They were hiring scientists out of the NIH with a molecule and an idea for a company. So, I started working with a lot of those nascent companies as they were getting started and developed the expertise in life sciences and spent the rest of my career with life sciences companies.

Q: What do you notice are the major differences between biomedical startups today and back then?

A: From a risk perspective, things have definitely changed. I think it was easier to raise money back then. The concept of failing early with molecules and accelerating the discovery process using rational drug design techniques wasn’t available back then and is now – so that would be a change. Back then, the focus was on gene therapy, and, while still popular, I think regenerative medicine has taken over. A lot of med device companies that were developing things for labs are now moving into the clinical setting with personalized medicine a purpose.

Q: Can you give me an example of how The Willis Group came to the aid of a biomedical company or academic research institution in recent times?
A: One of my favorite stories involves a large client that was making an acquisition and it was an orthopedic implant, a Class 3 medical device. During due diligence, our client learned that the company they were acquiring had received an FDA non-approvable letter because their sales and medical reps were recommending an alteration to the implantable orthopedic device during surgery. Our client thought that might be a problem, so asked for a large contingency hold-back in the buy-and-sell agreement. So, we stepped in and wrote a three-year risk or loss mitigation program with a per person coverage limit and a three-year policy aggregate for them. The program had a provision that, if no claims came after three years, our client could commute the policy and get their money back. The insurance company would keep the risk charge and the unused premium at the end of the policy would be returned to the client. The fact that we could transfer that risk from the balance sheet to a risk policy allowed the deal to go through.

Q: With clinical trials management moving overseas for many in the industry, what implications does this have for business moving forward?
A: Even the smallest R&D therapeutics company will take their trials oversees, so small companies become international companies very quickly. That’s a change we’ve identified. We are particularly adept at managing global foreign trials clinical programs. We have something called CTTrack which is a dashboard that allows clients to see where they are in relation to a deadline to meet with insurance and certificate requirements around the world. We maintain a matrix of all the requirements around the world. It is kept real-time on our clients’ desktop so that when they conduct a trial in Israel they can flip on the matrix and go to Israel and find out what the requirements are and what kind of lead time they need to conduct the clinical trials.

Q: What other new offerings does Willis Group provide its clients?
A: We’ve put together a unique program called Diagnostics 2.0. We come in and conduct a mini enterprise risk-management analysis. We conduct an in-depth interview that is designed to uncover the organizational risk. At the end of the process, we’ve done a diagnostic of the risk, so now we can deliver a customized risk/review report. Then, we can go in and look at the insurance programs structure, the pricing, the coverage and match it up with the risk diagnostic. It really peals the onion on risk exposure and it is unique to Willis.

CHI-Advancing California biomedical research and innovation

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